vinorelbine in treating children with recurrent or refractory cancers

Conditions: Brain and Central Nervous System Tumors; Neuroblastoma; Sarcoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.

objectives: i. determine the response rate of children with recurrent or refractory malignancies treated with vinorelbine. ii. assess the toxic effects of this drug in these children. outline: patients receive vinorelbine iv over 6-10 minutes weekly on weeks 1-6. treatment repeats every 8 weeks for a total of 10 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter. projected accrual: a maximum of 100 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: histologically confirmed recurrent or refractory solid malignant tumors of childhood including: soft tissue sarcoma rhabdomyosarcoma nonrhabdomyosarcoma extraosseous ewing's sarcoma cns tumors astrocytoma primitive neuroectodermal tumor atypical teratoid/rhabdoid tumors ependymoma recurrent neuroblastoma measurable disease no more than 2 prior treatment regimens patient characteristics: age: 21 and under at diagnosis performance status: ecog 0-2 life expectancy: at least 2 months hematopoietic: for patients with solid tumors (unless marrow involvement): absolute neutrophil count (anc) at least 1000/mm3 platelet count at least 100,000/mm3 (transfusion independent) hemoglobin at least 10 g/dl (rbc transfusions allowed) for patients post bone marrow transplantation: anc at least 1,000/mm3 platelet count at least 50,000/mm3 (transfusion independent) hemoglobin at least 10 g/dl (rbc transfusions allowed) hepatic: total bilirubin no greater than 1.5 times normal sgot/sgpt less than 2.5 times normal renal: creatinine no greater than 1.5 times normal or creatinine clearance or radioisotope glomerular filtration rate at least 70 ml/min neurologic: seizure disorder allowed if well controlled cns toxicity no greater than grade 2 prior concurrent therapy: biologic therapy: at least 6 months since prior bone marrow transplantation no concurrent immunomodulating agents chemotherapy: at least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered no other concurrent chemotherapy endocrine therapy: no concurrent corticosteroids except for increased intracranial pressure due to cns tumors radiotherapy: at least 6 months since prior radiotherapy to craniospinal axis, spine, and/or more than 50% of the bony pelvis concurrent radiotherapy to localized painful lesions allowed if at least one measurable lesion is not in radiation field surgery: not specified other: no concurrent participation in another ccg, pog, or cog therapeutic study

Keywords: recurrent childhood rhabdomyosarcoma recurrent neuroblastoma recurrent childhood soft tissue sarcoma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent childhood ependymoma